Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - A

Launched by CHONG KUN DANG PHARMACEUTICAL · Jun 12, 2016

Keywords

ClinConnect Summary

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Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy male volunteer in the age between 19 and 45 years old.
• • 2. Body weight ≥ 55 kg and Body weight in the range of calculated IBW ±20%.
• • 3. Subjects without a hereditary problems and chronic disease.
• • 4. Subjects whose clinical laboratory test values are inside the accepted normal range.
• • 5. Understand the requirements of the study and voluntarily consent to participate in the study.
• Exclusion Criteria:
• • 1. Previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system.
• • 2. History of gastrointestinal disease or gastrointestinal surgery to affect drug absorption.
• • 3. History of clinically significant allergies of amlodipine or candesartan or CCB or ARB or aspirin or antibiotic.
• • 4. Subjects with galactose intolerance.
• • 5. SBP ≥ 140 mmHg or\< 90 mmHg, DBP ≥ 95 mmHg or \< 60 mmHg, pulse ≥ 100 BPM.
• • 6. AST or ALT \> 2\*ULN, total bilirubin \> 2\*ULN
• • 7. Serum Creatinine \> ULN
• • 8. Previous history or present of drug abuse.
• • 9. Subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing.
• • 10. Subjects treated ethical drug or herbal medicine within 2 weeks, OTC or vitamin within 1 week prior to the first dosing.
• • 11. Subjects treated IP within 2 months prior to the first dosing.
• • 12. Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
• • 13. Alcohol \> 21 units/week or cannot stop drinking.
• • 14. Cigarette \> 10 cigarettes/day.
• • 15. Subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - LASIK, LASEK).
• • 16. Not eligible to participate for the study at the discretion of investigator.